Hypertension (HTN)IN-HOME BPNCT07232017
Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic
An observational study of Hypertension (HTN), run by Anita Misra-Hebert at 1 site in United States.
Trial summary
The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- IN-HOME BP
- How many people
- 1,520 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Per inclusion criteria and that the patient has at least 2 encounters with a HTN diagnosis within the past 24 months; had an encounter within the past 12 months at their PCPs assigned location; had a documented systolic blood pressure of >150 or diastolic blood pressure of >95 at the most recent encounter at the primary care location, and a previous encounter within the health system within the past 24-month qualifying time frame with a documented systolic blood pressure of >150 or diastolic blood pressure of >95.
Who may be able to join
- Hypertension diagnosis, aged 18-85 years old
- Uncontrolled blood pressure, defined as a blood pressure reading of > 150/95
Who cannot join
- pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.
Read the detailed description
Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.
Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)
- Quantitative assessment of practice variation in HTN control.
- Qualitative assessment of practice barriers and facilitators to HTN management.
- Creation of a clinical decision support tool for program referral.
- Creation of project-specific patient and employee Advisory Panel.
- Pharmacist and advanced practice provider (APP) training for delivery of the program.
- Practice facilitation training with the Cleveland Clinic continuous improvement team.
- Community Health Worker/Primary Care Navigator Training for Patient Outreach.
- Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months)
- Stepped wedge rollout of intensive HTN management program.
- Implementation of the clinical decision support tool at implementation sites.
- Community Health Worker/Primary Care Navigator outreach to patients.
- Delivery of Presentations at primary care staff meetings.
- Practice Facilitation at Implementation Sites.
- Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility.
- Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility.
- Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months)
- Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase.
- Capture practice-level adaptations with comparison to the active implementation phase.
- Complete final data collection and analyses.
- Conditions
- Hypertension (HTN)
- Being tested
- IN-HOME BP
- Keywords
- hypertension, uncontrolled blood pressure, home blood pressure, pharmacist, advanced practice provider
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-HOME BPOther
A team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.
| Study group | Role | What they receive |
|---|---|---|
| IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings | This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings. Receives: Other: IN-HOME BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure Change
The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period.
Measured: Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.
Secondary outcomes (23)
Diastolic Blood Pressure Change
Change in the patient's diastolic blood pressure from baseline as measured in mmHg.
Measured: The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.
Reach (Actual): Patients Offered, Initiated, Completed
Number of patients who were offered, who initiated, and completed the intensive HTN intervention program. Measured by total number at sorted by each: offered, initiated, completed.
Measured: Measured every 3 months for up to 33 months.
Effectiveness: Equity in Outcomes (Race)
Blood pressure change stratified by demographic factors, specifically race. Measured as percentage of black, white, and other.
Measured: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Ethnicity)
Blood pressure change stratified by demographic factors, specifically ethnicity. Measured by percentage of Hispanic and non-Hispanic
Measured: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Gender)
Blood pressure change stratified by demographic factors, specifically gender. Measured by percentage of male and female.
Measured: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Age)
Blood pressure change stratified by demographic factors, specifically age group. Measured in years.
Measured: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Insurance)
Blood pressure change stratified by demographic factors, specifically insurance. Measured in number of insurance: Medicare, Medicaid, Commercial, Self-pay.
Measured: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication change
Change from baseline medication regimen (medication class and dosage).
Measured: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication Adherence
Pharmacy Fill Data
Measured: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Cardiovascular outcomes
Sustained blood pressure control resulting in decreased cardiovascular risk: reported myocardial infarction, acute coronary syndrome, stroke, heart failure, arrhythmia, and death.
Measured: Baseline, and every 6 months through maintenance: for up to 33 months.
Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR).
Assessing acute renal failure by change in glomerular filtration rate (GFR) as measured in milliliters/minute/1.73 meters squared.
Measured: Every 6 months through maintenance: for up to 33 months.
Effectiveness: PROMIS-10 Survey
See improvement of patient report outcomes captured at pre-visit PROMIS-10 survey(12) administration as part of routine clinical care. As measured by assessing scores over time.
Measured: Baseline at intake visit then at 12 months: up to 24-months.
Effectiveness: Adverse Effects
Patient reported adverse effects at follow-up visits during intervention. Measured as number of effects reported by patient.
Measured: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Implementation: Provider views of the Acceptability, Appropriateness, and Feasibility survey
Captured through surveys, provider views of Acceptability, Appropriateness, Feasibility (13). Providers views of intervention may impact adoption of intervention for patients. Measured by change in item scored over time.
Measured: Every 6 months starting throughout active implementation and maintenance: for up to 33 months.
Primary Care Provider Adoption
Number of providers in each practice group referring to the Intensive HTN program will be measured by the number of referrals attributed to practice group.
Measured: Every 3 months during intervention period: for up to 24 months
Pharmacist Adoption
Number of patients in the program attributed to the trained pharmacy providers eligible to deliver the program.
Measured: Every 3 months during intervention period: for up to 24 months.
Advanced Practice Provider Adoption
Number of patients in the program attributed to the trained Advanced Practice Providers (APP) eligible to deliver the program.
Measured: Every 3 months during intervention period: for up to 24 months.
Formal Qualitative Assessment of context of high proportion of HTN control and low proportion of HTN control practices: Pre-Implementation
To understand barriers and facilitators to achieving HTN control
- Semi-structured interviews with non-patient (employee) key stakeholders at practices with high/low proportion of HTN control
- Direct field observations of high-low referral practice sites Qualitative methodologists will analyze the qualitative data (transcripts and descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes.
Measured: Pre-Implementation: up to 12 months.
Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels
To examine anticipated barriers and facilitators to implementation and to assess ongoing implementation activities. Qualitative methodologists will analyze the qualitative data (fieldnotes) will be coded to reflect key domains of interest and emergent themes.
Measured: Quarterly meetings throughout pre- and active implementation: up to 36 months.
Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low proportion of HTN Control
Inviting a sample of patients receiving the intervention at high and low proportion of HTN control practices to participate in interviews to assess perceptions of acceptability of the intensive HTN management program.
Qualitative methodologists will analyze the qualitative data (transcripts) will be coded to reflect key domains of interest and emergent themes.
Measured: Baseline, 6 months, 12 months during active implementation: up to 24 months.
Formal Qualitative Assessment: Periodic Reflections with agents of implementation
Periodic reflections conducted with a subgroup of pool of primary care providers, pharmacists, and APPs across practice locations to understand barriers and facilitators to achieving hypertension control.
Qualitative methodologists will analyze the qualitative data (descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes.
Measured: Monthly or bimonthly throughout active implementation and maintenance: for up to 33 months.
Outcome measure type: Effectiveness (Hospitalizations / Emergency Department Visits)
Hospitalizations and Emergency Department Visits: number of acute care hospitalizations, number of emergency department visits. Determining association between intensive HTN management and acute care utilization.
Measured: Every 6 months: up to 33 months.
Outcome Measure Type: Effectiveness (Outpatient Visits)
Outpatient visits other than for the intensive HTN management program. Number of outpatient visits (in-clinic or virtual, primary care and specialty). To determine association between intensive HTN management and acute care utilization.
Measured: Every 6 months: up to 33 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start6 Jan 2026
- Primary completionApr 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anita Misra-Hebert
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Anita Misra-Hebert, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232017
- Sponsor's protocol ID
- 25-792
- Acronym
- IN-HOME BP
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data used for this study includes human research participant data that are sensitive and cannot be publicly shared due to legal and ethical restrictions by the Cleveland Clinic regulatory bodies, including the institutional review board and legal counsel. We will make our data sets available on request, under appropriate data use agreements with the specific parties interested in academic collaboration.
Publications
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
PubMed 19543809Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.
PubMed 36281763
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic
- ClinicalTrials.gov ID
- NCT07232017
- Acronym / sponsor ID
- IN-HOME BP / 25-792
- Conditions
- Hypertension (HTN)
- Keywords
- hypertension, uncontrolled blood pressure, home blood pressure, pharmacist, advanced practice provider
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,520 participants (estimated)
- Lead sponsor
- Anita Misra-HebertUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, The Cleveland Clinic
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.
Detailed description
Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.
Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)
- Quantitative assessment of practice variation in HTN control.
- Qualitative assessment of practice barriers and facilitators to HTN management.
- Creation of a clinical decision support tool for program referral.
- Creation of project-specific patient and employee Advisory Panel.
- Pharmacist and advanced practice provider (APP) training for delivery of the program.
- Practice facilitation training with the Cleveland Clinic continuous improvement team.
- Community Health Worker/Primary Care Navigator Training for Patient Outreach.
- Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months)
- Stepped wedge rollout of intensive HTN management program.
- Implementation of the clinical decision support tool at implementation sites.
- Community Health Worker/Primary Care Navigator outreach to patients.
- Delivery of Presentations at primary care staff meetings.
- Practice Facilitation at Implementation Sites.
- Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility.
- Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility.
- Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months)
- Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase.
- Capture practice-level adaptations with comparison to the active implementation phase.
- Complete final data collection and analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings | – | Other: IN-HOME BPThis project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Per inclusion criteria and that the patient has at least 2 encounters with a HTN diagnosis within the past 24 months; had an encounter within the past 12 months at their PCPs assigned location; had a documented systolic blood pressure of >150 or diastolic blood pressure of >95 at the most recent encounter at the primary care location, and a previous encounter within the health system within the past 24-month qualifying time frame with a documented systolic blood pressure of >150 or diastolic blood pressure of >95.
Key inclusion criteria (2 listed)
- Hypertension diagnosis, aged 18-85 years old
- Uncontrolled blood pressure, defined as a blood pressure reading of > 150/95
Key exclusion criteria (1 listed)
- pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-HOME BPA team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings. | Other | IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings |
Primary outcome
Systolic Blood Pressure Change
Time frame: Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.
The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period.
23 secondary outcomes
Diastolic Blood Pressure Change
Time frame: The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.
Reach (Actual): Patients Offered, Initiated, Completed
Time frame: Measured every 3 months for up to 33 months.
Effectiveness: Equity in Outcomes (Race)
Time frame: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Ethnicity)
Time frame: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Gender)
Time frame: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Age)
Time frame: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Equity in Outcomes (Insurance)
Time frame: Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication change
Time frame: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Medication Adherence
Time frame: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Effectiveness: Cardiovascular outcomes
Time frame: Baseline, and every 6 months through maintenance: for up to 33 months.
Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR).
Time frame: Every 6 months through maintenance: for up to 33 months.
Effectiveness: PROMIS-10 Survey
Time frame: Baseline at intake visit then at 12 months: up to 24-months.
Effectiveness: Adverse Effects
Time frame: Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.
Implementation: Provider views of the Acceptability, Appropriateness, and Feasibility survey
Time frame: Every 6 months starting throughout active implementation and maintenance: for up to 33 months.
Primary Care Provider Adoption
Time frame: Every 3 months during intervention period: for up to 24 months
Pharmacist Adoption
Time frame: Every 3 months during intervention period: for up to 24 months.
Advanced Practice Provider Adoption
Time frame: Every 3 months during intervention period: for up to 24 months.
Formal Qualitative Assessment of context of high proportion of HTN control and low proportion of HTN control practices: Pre-Implementation
Time frame: Pre-Implementation: up to 12 months.
Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels
Time frame: Quarterly meetings throughout pre- and active implementation: up to 36 months.
Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low proportion of HTN Control
Time frame: Baseline, 6 months, 12 months during active implementation: up to 24 months.
Formal Qualitative Assessment: Periodic Reflections with agents of implementation
Time frame: Monthly or bimonthly throughout active implementation and maintenance: for up to 33 months.
Outcome measure type: Effectiveness (Hospitalizations / Emergency Department Visits)
Time frame: Every 6 months: up to 33 months.
Outcome Measure Type: Effectiveness (Outpatient Visits)
Time frame: Every 6 months: up to 33 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 19543809Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
- Background: PubMed 36281763Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25.
- Individual participant dataSharing planned: No. Data used for this study includes human research participant data that are sensitive and cannot be publicly shared due to legal and ethical restrictions by the Cleveland Clinic regulatory bodies, including the institutional review board and legal counsel. We will make our data sets available on request, under appropriate data use agreements with the specific parties interested in academic collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension (HTN), run by Anita Misra-Hebert at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Misra-Hebert, MD, MPH, FACP (216-445-8542, MISRAA@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure Change (time frame: Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232017, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.